Preterm Fetal Growth Restriction and Developmental Care

Preterm Birth Clinical Trial

Official title:

Preterm Fetal Growth Restriction and Developmental Care

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00166660
• Other study ID #: R01HD046855
• Status: Unknown status
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 1, 2009
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: March 2009
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: Heidelise Als, PhD
• Phone: 617-355-8249
• Email: heidelise.Als[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).

Description:

The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure.

The study aims to test three related hypotheses:

1. Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally.

2. The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents.

3. The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible.

The study will:

1. Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age.

2. Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).

3. Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways.

The primary infant measures proposed will be brain functional (EEG coherence, neurobehavioral functioning) and brain structural assessments (MRI). The goal will be to examine the direct causal connections and correlations among population characteristics, the intervention, and ultimate outcome at 2w CA. The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population. The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants' neurodevelopment. It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance, especially in terms of behavioral/emotional adaptation, learning and school achievement, which are all critical for life success.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• Inborn at Brigham and Women's Hospital, Boston

• Gestational age =28 and =33 weeks

• Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity

• Less than 5th percentile in birthweight and head circumference for gestational age

Exclusion Criteria:

• Major chromosomal or congenital anomalies

• Major congenital infections

• Significant prenatal diagnosed focal brain lesions

• Uncontrolled maternal illness

• History of smoking, alcoholism, and use of illicit drugs

• History of significant maternal deprivation, abuse, or malnutrition

• No telephone access and/or insufficient English language facility

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• NIDCAP (Newborn Individualized Developmental Care)
The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Preterm Infants' Behavior (APIB)		2 weeks corrected age (2w CA)
Primary	Quantified Electroencephalography (qEEG)		2 weeks Corrected Age (2w CA)
Primary	Magnetic Resonance Imaging(MRI)		2 weeks Corrected Age (2w CA)
Secondary	Parent Stress Level		2 weeks Corrected Age (2w CA)